Blinatumomab

(Blincyto®)

Blincyto®

Drug updated on 11/1/2024

Dosage FormInjection (intravenous: 35 mcg)
Drug ClassBispecific CD19-directed CD3 T-cell engagers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults and pediatric patients one month and older with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%
  • Indicated for the treatment of adults and pediatric patients one month and older with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL)
  • Indicated for the treatment of adults and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute
  • lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy.

Latest News

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Summary
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  • This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
  • Ph+ ALL Treatment Outcomes: In patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), the three-agent regimen combining TKI (tyrosine kinase inhibitor), blinatumomab, and steroids achieved a pooled complete molecular response (CMR) rate of 81% (95% CI (confidence interval): 69%-89%), with a nearly 6-fold increased likelihood of CMR compared to TKI alone (OR (odds ratio): 5.98; 95% CI: 2.99-11.96) and a 5-fold increase in 1-year survival (OR: 5.1; 95% CI: 1.74-14.9).
  • Pediatric R/R B-ALL: In relapsed/refractory (R/R) B-ALL (B cell acute lymphoblastic leukemia) among pediatric patients, single-arm studies showed a complete remission (CR) rate of 0.56 (95% CI: 0.45-0.68) and an overall survival (OS) rate of 0.43 (95% CI: 0.32-0.54). In randomized controlled trials (RCTs), blinatumomab compared to chemotherapy improved OS (0.12; 95% CI: 0.05-0.19) and event-free survival (EFS) rates (2.16; 95% CI: 1.54-3.03).
  • R/R B-ALL and NHL Responses: In relapsed/refractory B-ALL and non-Hodgkin lymphoma (NHL), the pooled CR rate for ALL was 0.45 (95% CI: 0.37-0.53), with higher CR observed in patients with bone marrow blasts below 50% (0.75) compared to those with blasts at or above 50% (0.33).
  • Adult R/R BCP ALL: In adult R/R B-cell precursor (BCP) ALL, first salvage treatment resulted in a longer median OS (10.4 months) compared to second or later salvage (5.7 months; HR: 1.58; 95% CI: 1.26-1.97) and a higher remission rate (54% vs. 41%).
  • Adverse Events in Pediatric R/R B-ALL: In single-arm studies, the adverse event (AE) rate was 0.65 (95% CI: 0.54-0.76), with Grade ≥3 AEs observed in 80% (95% CI: 72%-88%), including Grade ≥3 neurological toxicity at 7% (95% CI: 4%-11%) and cytokine release syndrome (CRS) at 3% (95% CI: 2%-5%).
  • Comparison to Chemotherapy in Pediatric B-ALL: Blinatumomab was associated with a lower risk of serious AEs (RR: 0.56; 95% CI: 0.32-0.99), febrile neutropenia (RR: 0.13; 95% CI: 0.06-0.26), and infection (RR: 0.40; 95% CI: 0.29-0.56) compared to chemotherapy, though the risk of encephalopathy was higher (RR: 8.90; 95% CI: 1.08-73.29).
  • Safety in R/R BCP ALL During Salvage Treatment: Higher frequencies of cytokine release syndrome, febrile neutropenia, and infection were observed in patients undergoing second or later salvage treatments compared to first salvage.
  • Higher effectiveness was observed in Ph+ ALL patients treated with TKIs, blinatumomab, and steroids, particularly with ponatinib over dasatinib. In pediatric R/R B-ALL, CR rates were greater in patients with bone marrow blasts below 50%. Adult R/R BCP ALL showed improved outcomes with first salvage treatment compared to later salvage, and ALL patients had better response rates than NHL patients, with reduced tumor load further supporting clinical response in ALL.

Product Monograph / Prescribing Information

Document TitleYearSource
Blincyto (blinatumomab) Prescribing Information.2024 Amgen Inc., Thousand Oaks, California

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy of Chemotherapy-Free Regimens in the Treatment of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Systematic Review and Meta-Analysis2024Clinical Lymphoma
Cost and cost-effectiveness of immunotherapy in childhood ALL: A systematic review2024 EJHaem
Efficacy and Safety of Blinatumomab for the Treatment of Relapsed/Refractory Acute Lymphoblastic Leukemia: A Systemic Review and Meta-Analysis2023Clinical Lymphoma, Myeloma & Leukemia
Efficacy and safety of blinatumomab in children with relapsed/refractory B cell acute lymphoblastic leukemia: A systematic review and meta-analysis2022Frontiers in Pharmacology
The safety of blinatumomab in pediatric patients with acute lymphoblastic leukemia: A systematic review and meta-analysis2022 Frontiers in Pediatrics
Evidence-Based Recommendations for Nurse Monitoring and Management of Immunotherapy-Induced Cytokine Release Syndrome: A Systematic Review from the Children's Oncology Group2021 Journal of Pediatric Oncology Nursing
Blinatumomab in Pediatric Acute Lymphoblastic Leukemia-From Salvage to First Line Therapy (A Systematic Review)2021Journal of Clinical Medicine
Blinatumomab as first salvage versus second or later salvage in adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia: Results of a pooled analysis2021Cancer Medicine
A Systematic Review of Blinatumomab in the Treatment of Acute Lymphoblastic Leukemia: Engaging an Old Problem With New Solutions2021The Annals of Pharmacotherapy
Commonly Reported Adverse Events Associated With Pediatric Immunotherapy: A Systematic Review From the Children's Oncology Group2021Journal of Pediatric Oncology Nursing
Efficacy and safety of bispecific T-cell engager (BiTE) antibody blinatumomab for the treatment of relapsed/refractory acute lymphoblastic leukemia and non-Hodgkin's lymphoma: a systemic review and meta-analysis2019Hematology (Amsterdam, Netherlands)

Clinical Practice Guidelines